FDA.reportPublic FDA data

FUNGAL NAIL TREATMENT kit .cream.

Product NDC
87870-002
11-digit product format
878700002
Labeler code
87870
Product ID
87870-002_56c9d9fa-09ae-e26a-e063-6394a90a0ed9
Type
HUMAN OTC DRUG
Nonproprietary name
Pseudolarix Amabilis Bark 1%
Dosage form
CREAM
Route
TOPICAL
Labeler
GETHSEMANE BRANCH CORPORATION
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-08-07
Substance
STEMONA JAPONICA ROOT; ATRACTYLODES LANCEA ROOT; COPTIS CHINENSIS ROOT; CAMPHOR (NATURAL); BORNEOL; PROPYLENE GLYCOL; SALICYLIC ACID; SOPHORA FLAVESCENS ROOT; PSEUDOLARIX AMABILIS BARK
Active strength
2; 1; 1; 1; 1.5; 1.5; 1; 1.5; 1 g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
FUNGAL NAIL TREATMENT kit .cream.
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
STEMONA JAPONICA ROOT2 g/100g
ATRACTYLODES LANCEA ROOT1 g/100g
COPTIS CHINENSIS ROOT1 g/100g
CAMPHOR (NATURAL)1 g/100g
BORNEOL1.5 g/100g
PROPYLENE GLYCOL1.5 g/100g
SALICYLIC ACID1 g/100g
SOPHORA FLAVESCENS ROOT1.5 g/100g
PSEUDOLARIX AMABILIS BARK1 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 9 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
FXG254HF10Internal UNII lookup
CAZ6282J2OInternal UNII lookup
CXS4LJR7ELInternal UNII lookup
N20HL7Q941Internal UNII lookup
M89NIB437XInternal UNII lookup
6DC9Q167V3Internal UNII lookup
O414PZ4LPZInternal UNII lookup
IYR6K8KQ5KInternal UNII lookup
49G13A93VEInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
56c9d9fa-09ad-e26a-e063-6394a90a0ed9Available on FDA.report

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 21 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Terramed Just Think Comfort Armor Antifungal MedicatedTOLNAFTATERida LLC33994035-b429-4ead-8885-98e38b25059a2026-02-04WarningsExact identifier
application number: M005
BeamBalm FUNGL NAILTOLNAFTATE 1% FUNGL NAILJiangxi Yudexi Pharmaceutical Co., LTD49f72e97-2393-dca8-e063-6394a90a6f102026-02-03WarningsExact identifier
application number: M005
MARIANP FUNGAL NAIL PATCHESTEA TREE OILShenzhen Shandian Jingling Technology Co., Ltd.49d1dbc4-91be-1f5c-e063-6394a90a55ec2026-02-02WarningsExact identifier
application number: M005
Jorvinl Nail Fungus TreatmentUNDECYLENIC ACID 25%Guangzhou Huixue Biotechnology Co., Ltd.49d88844-9cb0-f575-e063-6394a90a0d2f2026-02-02WarningsExact identifier
application number: M005
FlyLeaf Fungal Nail TreatmentTOLNAFTATE 1%Guangzhou Huixue Biotechnology Co., Ltd.49d8e823-b7a2-8c18-e063-6294a90a77452026-02-02WarningsExact identifier
application number: M005
BLDAXN FUNGUS NAIL PENUNDECYLENIC ACID, TOLNAFTATEGuangdong Quadrant Ecological Technology Co., Ltd.49e291e1-be83-8926-e063-6394a90a13c22026-02-02WarningsExact identifier
application number: M005
INSTANT HAND SANITIZERINSTANT HAND SANITIZERNINGBO MEITELI COSMETICS CO., LTD49e44671-5d79-aa8e-e063-6294a90a9d2e2026-02-02WarningsExact identifier
application number: M005
Alveora FOOT ODOR PROBIOTICTOLNAFTATE 1% FOOT ODOR PROBIOTICJiangxi Yudexi Pharmaceutical Co., LTD49964c81-1c86-e1f5-e063-6394a90a7d082026-01-30WarningsExact identifier
application number: M005
Alveora NAIL FUNGUS TREATMENTALVEORA NAIL FUNGUS TREATMENTJiangxi Yudexi Pharmaceutical Co., LTD49985b01-ef96-0d27-e063-6294a90ac1692026-01-30WarningsExact identifier
application number: M005
ProClearz Laser AntifungalTOLNAFTATERooftop Consumer Health, inc53648135-7b79-4775-993b-48fa1298b7472026-01-29WarningsExact identifier
application number: M005
Proclearz Professional Fungal ShieldTOLNAFTATERooftop Consumer health, inc51125209-c279-4abb-af07-500982651cab2026-01-29WarningsExact identifier
application number: M005
TheraCare Antifungal CreamTOLNAFTATEVeridian Healthcaree9478d74-c0d9-4b88-a474-b88d10f525712026-01-29WarningsExact identifier
application number: M005
BLDAXN NAIL REPAIR PENUNDECYLENIC ACIDGuangdong Quadrant Ecological Technology Co., Ltd.4992fbd8-f205-2ff6-e063-6394a90a7d062026-01-29WarningsExact identifier
application number: M005
Jock Itch Clotrimazole AntifungalCLOTRIMAZOLEWalMarta7677ad4-5239-40da-809a-501b91caedbf2026-01-29WarningsExact identifier
application number: M005
ProCure AntifungalMICONAZOLE NITRATE 2%Twin Med LLC3d380fe4-a870-cb55-e063-6394a90a9c902026-01-28WarningsExact identifier
application number: M005
Antifungal LiquidTOLNAFTATEWal-Mart Stores, Inc.401f4993-0200-f1fd-e063-6294a90a65892026-01-28WarningsExact identifier
application number: M005
Foot PowderMICONAZOLE NITRATEWalgreens Company137a493b-6ed5-d649-e063-6294a90ac4422026-01-28WarningsExact identifier
application number: M005
Miconazole NitrateJOCK ITCH SPRAYWal-Mart Stores, Inc.76259769-9923-4856-a160-a738bc8a72f02026-01-27WarningsExact identifier
application number: M005
Signature Select Instant Hand Sanitizer Wipes with Aloe VeraALCOHOLLiving Better Brands LLCcf4b671f-697a-47d3-921e-2de4330739182026-01-26WarningsExact identifier
application number: M005
Signature Select Advanced Hand Sanitizer with Aloe VeraALCOHOLLiving Better Brands LLCcbf0fead-0729-460b-82c0-1596c995cf2b2026-01-26WarningsExact identifier
application number: M005

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
87870-002-018787000020120 g in 1 TUBE (87870-002-01) 20 g2026-08-07NoNoCurrent